Molecular Diagnostics
News on lab-developed tests and emerging diagnostic technologies.
Euformatics Gains CE-IVD Mark for OmnomicsNGS
Euformatics has updated the marking on its variant interpretation and reporting software as the firm prepares for the EU's new IVDR scheme.
Audere Gets FDA Emergency Use Authorization for SARS-CoV-2 At-Home Sample Collection Kit
The kit, developed by digital health firm Audere, is designed for the collection of anterior nasal swab specimens for molecular COVID-19 testing in children and adults.
With new financing from Koch Disruptive Technologies and guidance from industry experts, the firm expects to launch its system next year.
Caris Life Sciences Facing FTC Lawsuit After Resisting Subpoena in Illumina, Grail Antitrust Case
Caris said it has already provided materials to Illumina and should not have to indulge a "fishing expedition for irrelevant, highly sensitive details."
Biodesix, Spesana Partner to Improve Workflows for Lung Cancer Molecular Diagnostic Tests
Startup Spesana's digital platform will integrate EMR, lab information, and MDx data to automate clinical workflows, tumor boards, and clinical trial management.